Faricimab 21mg/0.175ml solution for injection pre-filled syringes

To evaluate the outcomes of intravitreal faricimab (IVF; Vabysmo®) in previously treated patients with wet age-related macular degeneration (wAMD), focusing on best available visual acuity (BAVA), central subfield thickness (CST), injection interval, complications, fluid resolution, and reversion rates to prior therapies. The PubMed, Embase, and Google Scholar databases were searched for studies reporting outcomes of treatments for previously treated cases of wAMD. Mean differences (MD) with 95% confidence intervals (CI) were used to compute the effect size of the change in outcomes. A total of 29 studies with 2070 patients (1003 women, mean age 78.9 years) and 2128 eyes were included. BAVA and CST were reported in 28 studies, fluid status in 21, injection interval in 14, and reversion rates in 6. Pooled analysis showed significant but modest improvement in BAVA when IVF was given for > 6 months (MD = −0.026 LogMAR, p < 0.05) but not at earlier follow-ups. A similar trend was noted with injection interval extension when IVF was given beyond 6 months (MD = +2.1 weeks, p < 0.05). CST reduction was observed at all time points (overall MD = −37.7 μm, p < 0.05). Complication rates were reported in nine studies, with an overall rate of 1.2%, including retinal pigment epithelium tear, intraocular inflammation, endophthalmitis, and subretinal hemorrhage. Reversion to prior or other anti-vascular endothelial growth factor (anti-VEGF) therapy was reported in six studies, occurring in 23% of eyes. We reported the outcomes of utilizing IVF in previously treated cases of wAMD. IVF showed a significant improvement in CST at all time points and in the extension of injection interval. Visual outcomes remained unchanged when followed for less than 6 months but improved significantly but modestly when followed for more than 6 months. Switching to intravitreal faricimab may be a useful treatment option for previously treated patients with wAMD, with a goal of reducing treatment burden and improving treatment efficacy.

Abstract licence: CC BY-NC

Background/Objectives: To evaluate the incidence, characteristics, and clinical outcomes of intraocular inflammation (IOI) associated with intravitreal faricimab (IVF) in patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Methods: Following PRISMA guidelines, a comprehensive search of PubMed, Web of Science, Scopus, Embase, and CENTRAL databases was performed from their inception to February 2025. Using the random-effects model, weighted proportions, standardized mean differences, and weighted log odds ratios (OR) were pooled and calculated. A two-tailed p-value of &lt;0.05 was considered statistically significant. The χ2 (z) test and the Higgins I2 test were used to assess studies heterogeneity. Results: We conducted a systematic review and meta-analysis of 24 studies (4,761 patients; 5,652 eyes). The most common diagnoses were nAMD (n = 4,782, 94.6%) and DME (n = 845, 37.1%). The pooled proportion for IOI incidence in eyes receiving IVF was 3.0% (95% CI: 1.0 – 6.0). The odds of developing IOI are significantly lower in the DME group compared to the nAMD group (OR: 0.89, p &lt;0.01). Unspecified IOI was the most common sign (n = 210, 2.9% [95% CI: 1.2 – 7.3]), followed by anterior uveitis (n = 80, 1.9% [95% CI: 0.1 – 34.8]), vitritis (n = 63, 2.9% [95% CI: 0.2 – 32.1]), retinal hemorrhage (n = 27, 0.7% [95% CI: 0.0 – 15.3]), and endophthalmitis (n = 8, 0.5% [95% CI: 0.3 – 1.1]). Conclusions: While IVF demonstrates therapeutic efficacy, our findings highlight a clinically relevant risk of IOI. We, therefore, recommend vigilant monitoring for all patients receiving IVF, especially those with nAMD.

Abstract licence: CC BY 4.0

BackgroundFaricimab is a bispecific monoclonal antibody targeting both vascular endothelial growth factor A and angiopoietin-2, approved for macular oedema secondary to retinal vein occlusion in 2023. The phase III BALATON and COMINO trials demonstrated non-inferiority to aflibercept at week 24, and several real-world cohorts have subsequently emerged. The aim of this systematic review and meta-analysis was to estimate the pooled effect of faricimab on visual acuity, treatment burden, anatomical outcomes, and safety in this indication.MethodsPubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched from inception to 1 May 2026 for studies reporting outcomes following intravitreal faricimab. Risk of bias was assessed in duplicate using the Cochrane Risk of Bias 2 tool for the randomised evidence and the Risk Of Bias In Non-randomised Studies of Interventions tool for the observational evidence, with single-arm cohorts evaluated as pre-post comparisons. The primary visual acuity outcome was pooled using random-effects meta-analysis with Hartung-Knapp-Sidik-Jonkman adjustment, stratified by treatment status, while outcomes precluded from pooling by methodological heterogeneity were synthesised narratively. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation framework.ResultsTen studies comprising 1,620 eyes met eligibility criteria, including the BALATON and COMINO randomised controlled trials and nine non-randomised cohorts. The pooled mean change in best-corrected visual acuity at approximately 6 months was + 16.89 Early Treatment Diabetic Retinopathy Study letters (95% confidence interval 16.05 to 17.72) in treatment-naïve eyes and + 8.73 letters (95% confidence interval 4.75 to 12.71) in refractory switch cohorts, with negligible between-study heterogeneity in both analyses. Narrative synthesis was consistent with treatment interval extension following initiation of or switch to faricimab, statistically significant reductions in central retinal thickness across studies, and a short-term safety profile without identified retinal vasculitis events.ConclusionThe synthesis is consistent with intravitreal faricimab use being associated with visual and anatomical improvement in macular oedema secondary to retinal vein occlusion, with the treatment-naïve pooled estimate primarily reflecting registration trial data and the switch cohort estimate characterising refractory phenotypes.

Abstract licence: CC BY